Related Manuals for Olympus WA4KL100 ULTRA
Summary of Contents for Olympus WA4KL100 ULTRA
- Page 1 INSTRUCTIONS FOR USE TELESCOPE ULTRA WA4KL100 WA4KL500 WA4KL130 WA4KL530 WA4KL145 WA4KL545...
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Page 3: Table Of Contents
Contents 1 General information ..............5 1.1 User instructions ..............5 1.2 Signal words ................5 1.3 Conventions throughout this document ........5 1.4 Trademarks ................6 1.5 Manufacturer ................6 2 Safety information ..............7 2.1 Intended use ................7 2.2 Contraindications .............. - Page 4 7.3 Manual cleaning ..............30 7.4 Manual disinfection .............. 32 7.5 Automated cleaning and thermal disinfection....... 33 7.6 Maintenance ................. 37 7.7 General information for sterilization ........37 7.8 Validated sterilization methods ..........38 7.9 Verified sterilization methods ..........42 7.10 Storage and handling ............
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Page 5: General Information
1.1 User instructions • Before use, thoroughly read the instructions for use. • If the instructions for use are missing, immediately contact an Olympus representative. • Keep the instructions for use in a safe, accessible location. 1.2 Signal words The following signal words are used throughout this document. -
Page 6: Trademarks
- Dashes indicate the listing of data, options or objects. 1) Numbers with right parenthesis name elements in illustrations. 1.4 Trademarks - STERRAD ® - NX - Cidex OPA ® are trademarks of their respective owner. 1.5 Manufacturer Olympus Winter & Ibe GmbH Kuehnstr. 61 22045 Hamburg Germany... -
Page 7: Safety Information
Safety information 2 Safety information 2.1 Intended use WA4KL100, WA4KL130, WA4KL145 The device is indicated for use in endoscopic surgery to visualize treatment and inspection of organs within the thoracic and abdominal cavities. The device is also indicated for visualization of transanal and transvaginal applications. -
Page 8: User Qualification
Repair Repair of the product may only be performed by trained qualified servicing personnel that has been authorized by Olympus. Otherwise, Olympus cannot be held responsible for the safety and performance of the product. 2.4 Environment of use Medical use This product is only intended to be used in hospitals and medical rooms with appropriate endoscopic equipment. - Page 9 Safety information WARNING Risk of injury to the patient and/or the user An insufficient understanding of the dangers, warnings, cautions, and instructions can result in serious injury or damage to the product. • Make sure to have the complete set of instructions for use. •...
- Page 10 • Do not attempt to repair or modify the product. • Repairs may only be performed by qualified servicing personnel that has been authorized by Olympus. • Contact an Olympus representative or an authorized service center for repair information.
- Page 11 Safety information CAUTION Risk of injury to the patient and/or the user Using incompatible equipment may lead to injury of the patient and/or the user as well as damage to the product. • For information on compatible equipment, refer to the chapter “Compatible equipment”...
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Page 12: Product Description
3 Product description 3.1 Scope of delivery • Before use, check that all items listed below are available. • Contact an Olympus representative or an authorized service center if any items are missing or damaged. WA4KL100, WA4KL130, WA4KL145, WA4KL500, WA4KL530,... - Page 13 Product description 3.2.1 Telescope WA4KL100, WA4KL130, WA4KL145 Entire telescope Main body 1) Insertion tube 2) Light-guide connector 3) Eyepiece cup...
- Page 14 Product description 3.2.2 Telescope WA4KL500, WA4KL530, WA4KL545 Entire telescope Main body 1) Insertion tube 2) Light-guide connector 3) Eyepiece cup 3.2.3 Distal end 1) Objective cover glass...
- Page 15 Product description 2) Light emission surface 3.2.4 Eyepiece cup 1) Eyepiece cover glass 3.2.5 Direction of view The direction of view is indicated in degree on the main body of the telescope.
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Page 16: Symbols
3.4 Warranty Any warranty claims towards Olympus are forfeited if the user or unauthorized persons attempt repair or modification of the product. No warranty is provided for any damage due to misuse... -
Page 17: Preparation
Preparation 4 Preparation 4.1 Safety information for preparation WARNING Risk of injury to the patient and/or the medical personnel Improper and/or incomplete reprocessing can cause infection of the patient and/or medical personnel as well as damage to the product. • Reprocess the product before first and each subsequent use. •... - Page 18 Preparation General inspection of the telescope • Check that the product has: - no dents, cracks, bending, or deformations - no deep scratches - no corrosion - no lens damages or cover glass damages - no missing or loose parts •...
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Page 19: Assembly And Connection
Preparation • Check that the image is not cloudy, out of focus or dark. 4.3 Assembly and connection If force is required for assembly: 1. Check the compatibility of the equipment. 2. If necessary, dispose of the product and use another one. 4.3.1 Selecting compatible system components •... - Page 20 Preparation 1. Connect the light-guide cable to the light-guide connector of the telescope. 2. Screw the light-guide cable onto the thread of the light-guide connector. 4.3.3 Connecting the video adapter and/or camera head • Refer to the chapter “Compatible equipment” on page 47 to identify the compatible equipment.
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Page 21: Use
5 Use 5.1 Safety information for use WARNING Risk of injury to the patient There is a risk of electric shock if the following conditions apply simultaneously: - The telescope is inserted in the patient. - The light-guide cable is connected to the telescope but not to the light source. - Page 22 • Set the output power of the light source to the minimum level that is necessary for a sufficient illumination of the target area. Avoid prolonged exposure to intense illumination. • Switch off the light source or set the light source to standby mode whenever the light source is not in use.
- Page 23 • Only ignite when the laser emission part is visible on the endoscopic image.
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Page 24: After Use
• Reprocess this product immediately after use. Do not leave used instruments overnight before reprocessing. • Olympus recommends to return the product from the point of use to the cleaning area in dry condition to avoid protein fixation caused by detergents or disinfectants. - Page 25 After use • Remove heavy debris from the product by wiping with an appropriate, single-use lint-free cloth or sponge. • Separate telescopes from other instruments. • Immediately after use, bring the product to the reprocessing area. Transport to the reprocessing area The product can be transported in a wet or dry condition.
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Page 26: Reprocessing
Reprocessing 7 Reprocessing 7.1 Safety information for reprocessing WARNING Risk of injury to the patient and/or the medical personnel Improper and/or incomplete reprocessing can cause infection of the patient and/or medical personnel as well as damage to the product. • Reprocess the product before first and each subsequent use. •... -
Page 27: General Information For Reprocessing
Automatic methods reduce these risks and provide the advantage of standardized, reproducible and validated procedures. Therefore, Olympus recommends to generally prefer automatic cleaning methods. Validated for efficacy Validated for efficacy means that the efficacy of the method or agent has been validated for reprocessing this product as described in this document. - Page 28 For detailed information on validated reprocessing methods, refer to the instructions following the table. Method validated for microbiological/cleaning efficacy and verified for material compatibility Method verified for material compatibility – Incompatible Contact an Olympus representative for additional information. Not tested...
- Page 29 Reprocessing Process All products covered in this document Preparation at Deposition the point of use Decontamination Preparation Selection according to the cleaning and disinfection procedures Cleaning Manual Ultrasonic – Alkaline detergent Acidic detergent Neutral detergent Machine Alkaline detergent Acidic detergent Neutral detergent Rinsing Disinfection...
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Page 30: Manual Cleaning
Reprocessing Cleaning brush In the following reprocessing instructions, Olympus uses the term “appropriate surface brush”. Select an appropriate surface brush according to the following information: • A surface brush is for outer surfaces only. Do not use a lumen brush for surfaces. - Page 31 Reprocessing NOTICE Risk of damage to the product Incompatible detergents may considerably damage Olympus endoscopes and accessories. • Use only solutions that are approved and verified (for example by FDA, DGHM or a comparable institution) and that are certified by their manufacturers as safe for endoscopic instrument cleaning and disinfection.
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Page 32: Manual Disinfection
7.4 Manual disinfection NOTICE Risk of damage to the product Incompatible disinfectants may considerably damage Olympus endoscopes and accessories. • Use only solutions that are approved and verified (for example by FDA, DGHM or a comparable institution) and that are certified by their manufacturers as safe for endoscopic instrument cleaning and disinfection. -
Page 33: Automated Cleaning And Thermal Disinfection
Reprocessing 7.4.1 Precondition for manual disinfection The product must be cleaned thoroughly before disinfection. Thorough cleaning removes both micro-organisms and organic material. Failure to remove organic material decreases the effectiveness of the disinfection process. • To avoid damaging the product, it is recommended to use commercially available grasping forceps with rubber-padded jaws to handle the product once it is immersed. - Page 34 Reprocessing WARNING Risk of injury to the patient When using plastic instrument trays for automated cleaning and thermal disinfection, the detergent may not come in contact with all parts of the endoscope. Ineffective cleaning and disinfection may lead to infection of the patient. •...
- Page 35 Reprocessing Automated cleaning of the product has been validated with the following detergents: - Neodisher MediClean forte manufactured by Chemische Fabrik Dr. Weigert GmbH und Co. KG - 0.5% solution - pH value: approx. 10.3 - Neodisher Z manufactured by Chemische Fabrik Dr. Weigert GmbH und Co.
- Page 36 Reprocessing - A temperature of 55 °C must not be exceeded during cleaning. • Do not use programs starting with high temperatures (e.g., 93 °C). This causes thermal coagulation of proteins. • Make sure that the program does not include any sudden changes in temperature.
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Page 37: Maintenance
Reprocessing 7.6 Maintenance Inspecting the telescope • Visually inspect the product thoroughly after cleaning. The product must be visually clean. If there are any signs of debris, repeat the cleaning process. • Observe the instructions in the section “Inspection” on page 17. -
Page 38: Validated Sterilization Methods
Reprocessing 7.8 Validated sterilization methods Sterilization of the product has been validated with steam sterilization and STERRAD sterilization. ® • Choose one of the sterilization methods. • For steam sterilization, refer to the section “Steam sterilization” on page 38. • For STERRAD sterilization, refer to the section “STERRAD ®... - Page 39 Reprocessing 3. Press the telescope into the notches. 4. Close the instrument tray. 5. Seal the instrument tray in packaging appropriate for sterilization according to local guidelines and your hospital’s protocol. Use of instrument trays • Do not stack the instrument trays or load them on their side edges during steam sterilization.
- Page 40 Sudden changes in temperature may damage the product. Steam sterilization procedure For steam sterilization, Olympus recommends a drying time of at least 15–30 minutes. • Choose an appropriate drying time, depending on the autoclave.
- Page 41 Reprocessing Example for fractionated prevacuum steam sterilization 1) Evacuation 2) Steaming and evacuation 2x 3) Heating 4) Sterilization 5) Evacuation 6) Drying 7) Aeration 7.8.2 STERRAD sterilization ® CAUTION Risk of injury to the patient Performing a STERRAD sterilization with the endoscope in the ®...
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Page 42: Verified Sterilization Methods
Reprocessing • When sterilizing the endoscope in the plastic instrument tray, do not use STERRAD ® Preparing the product for STERRAD plasma sterilization ® • Place the product in sterilizing pouches or containers (any container/pouches must be certified by its manufacturer for STERRAD use). - Page 43 Reprocessing 7.9.1 Gas Sterilization WARNING Risk of injury to the patient and/or the medical personnel Residual water can affect the gas sterilization process and lead to insufficient reprocessing. • Thoroughly clean and dry the instruments before gas sterilization. WARNING Risk of injury to the patient and the user Toxic gasses can enter internal volumes of the product during gas sterilization.
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Page 44: Storage And Handling
Reprocessing 7.10 Storage and handling NOTICE Risk of damage to the product If the product is stored or transported with other devices without use of an instrument tray, product damage may occur. • Use instrument trays to store or transport the product. •... -
Page 45: Repair, Shipment And Disposal
Olympus. Contact an Olympus representative or an authorized service center for repair and warranty information. Otherwise, Olympus can not be held responsible for the safety, reliability, and performance of the product. Loss of warranty Any guarantee or warranty claims are forfeited if the user or an unauthorized servicing agency attempts repair of a product. -
Page 46: Shipment
8.2 Shipment WARNING Risk of infection for the servicing personnel Sending used products to Olympus represents a risk of infection for the personnel. Olympus is entitled to refuse soiled or contaminated products for reasons of safety. • Reprocess the product before sending in. -
Page 47: Compatible Equipment
Compatible equipment 9 Compatible equipment Olympus recommends the use of equipment as listed in this chapter. If combinations are used that are not listed in this chapter, the user takes the full responsibility. Future equipment may also be compatible. For more information, contact an Olympus representative. -
Page 48: For 5.4 Mm Telescopes
Compatible equipment 9.1 For 5.4 mm telescopes A0464 O0332 A0460 WA4KL500 WA4KL530 WA4KL545 Product description Article number Instrument trays and wire baskets e.g. WA05990A, A5940 Light-guide cable e.g. WA03310A High-resolution camera head e. g. CH-S190-XZ-E, OTV-S7 ProH- HD-10E, OTV-S7 ProH-HD-12E **** 5.5 mm trocars e.g. -
Page 49: For 10 Mm Telescopes
Compatible equipment 9.2 For 10 mm telescopes A0464 O0332 A0460 WA4KL100 WA4KL130 WA4KL145 Product description Article number Instrument trays and wire baskets e.g. WA05990A, A5940 Light-guide cable e.g. WA03310A High-resolution camera head e. g. CH-S190-XZ-E, OTV-S7 ProH- HD-10E, OTV-S7 ProH-HD-12E **** 11 mm trocars e.g. -
Page 50: Technical Data
Technical data 10 Technical data 10.1 General dimensions 10.1.1 Telescope Working length WA4KL100 ..............316.4 mm WA4KL130 ..............318.6 mm WA4KL145 ..............319.2 mm WA4KL500 ..............315.8 mm WA4KL530 ..............317.0 mm WA4KL545 ..............317.0 mm Maximum insertion portion width WA4KL100, WA4KL130, WA4KL145 ....... - Page 51 Technical data Storage conditions Temperature .........10 to 40 °C (50 to 104 °F) Relative humidity ............30 to 85% Transport conditions Temperature ........−40 to 70 °C (−40 to 158 °F) Relative humidity ............10 to 95%...
- Page 56 W7510750_06 2018-06-07 © Copyright 2018 Olympus Winter & Ibe GmbH...
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